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Method and composition for skin inflammation and discoloration

Inactive Publication Date: 2009-12-10
FAIRFIELD CLINICAL TRIALS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, there can be swelling of the soft tissues beneath the eyes, due to increased permeability of post-capillary venules or peri-orbital fat herniation.
Although the degree of swelling around the eyes comes and goes, once it occurs, it rarely resolves spontaneously.
These agents are of limited effect and, even when applied topically, may produce some systemic effects, acting as neurotransmitters which can adversely affect cardiac rhythm and / or blood pressure.
This is a major drawback to the prior art compositions.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Double-Blind Placebo-Controlled Human Study of Topical Preparation

[0036]An embodiment of the inventive composition, referred to as the “test article” in this example, contained 1% 2-[4-(2-methylpropyl) phenyl] propanoic acid and fexofenadine in a vehicle of Kiehl's® brand Eye Alert®, a commercially available eye cream. The compositions were prepared aseptically. The test article and vehicle alone were placed in numbered, blinded syringes, with a safety cap in place.

[0037]In a double-blinded, placebo-controlled study in humans, 59 male and female patients, 18 years of age and older, received either test article (inventive composition) or vehicle alone (control) to apply topically to the under-eye area of the skin after informed consent was obtained. Each patient applied the test article to one side and the vehicle to the other, using a clean cotton-tipped applicator for each application per side, so that each patient could serve as her own control. The patients received two syringes,...

example 2

Effectiveness of Oral Combination Therapy Compared to Topical Combination Therapy in Humans

[0041]After informed consents were obtained, seven women, age 18 or older, received oral medication, 100 mg Ibuprofen and 60 mg Fexofenadine, to be taken twice daily for one week. The medications were delivered in a blister pack to lessen the chance of dosing error and to increase compliance. The blister packs for the oral medication were returned at the end of Week 1. At that time, the women received a topical treatment composition containing 1% Fexofenadine and 1% Ibuprofen, dissolved in a stable and commercially available eye cream, to be applied to each side under the eyes, twice a day, using a clean cotton tipped applicator. Each applicator was to be used once only and for only one side. The patients returned the topical treatment composition at the end of Week 2 for weighing of the test article. Photographs of the peri-orbital areas of all patients were taken at entry, end of Week 1, and...

example 3

Effectiveness of Topical Single-Drug Therapy Compared to Topical Combination Therapy in Humans

[0042]After informed consent was obtained, six female patients, age 18 and older, received a composition according to an embodiment of the invention containing 1% Fexofenadine and 1% Ibuprofen in an inert eye cream and control compositions containing vehicle plus 1% Fexofenadine or vehicle plus 1% Ibuprofen. The patients were instructed to apply the products with a clean cotton tipped applicator topically to the under eye area, each on one side of the face, with a separate clean cotton tipped applicator.

[0043]During Week 1, the patients applied the combination product to one side and either fexofenadine alone or ibuprofen alone (chosen at random for the week) to the other side. During Week 2, treatment with the combination product was maintained on the same side of the face, while the other side was switched from one compound alone to the other (i.e., from fexofenadine to ibuprofen or from ...

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Abstract

The invention provides a method and compound for treating darkness and / or swelling / inflammation of the skin of humans. An antihistamine compound and a non-steroidal anti-inflammatory drug (NSAID) compound in combination have been found to effectively treat under eye darkness, swelling and puffiness in particular, when applied topically to the affected skin.

Description

CROSS REFERENCE TO APPLICATIONS[0001]This application claims benefit of U.S. Provisional Patent Application Ser. No. 61 / 057,700, filed May 30, 2008; Ser. No. 61 / 088,440, filed Aug. 13, 2008; Ser. No. 61 / 118,191, filed Nov. 26, 2008; and Ser. No. 61 / 159,984, filed Mar. 13, 2009. The disclosures of each of these provisional applications is incorporated by reference herein in its entirety.BACKGROUND OF THE INVENTION[0002]1. Technical Field[0003]This invention generally relates to the field of medical dermatology, allergy and cosmetics. This application describes a topically applied medical treatment composition and methods, which provide improvement in the cosmetic appearance of the dark circles and / or swelling / inflammation that can occur beneath the eyes of humans.[0004]2. Description of the Background Art[0005]Most people will develop a darkening of the skin below or around their eyes at various times in their lives. These dark areas (also known as dark circles or “allergic shiners” ...

Claims

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Application Information

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IPC IPC(8): A61K31/60A61K31/445A61P11/02
CPCA61K31/18A61K31/19A61K45/06A61K31/60A61K31/55A61K31/196A61K31/405A61K31/407A61K31/445A61K31/4545A61K31/495A61K31/54A61K2300/00A61P11/02A61P17/00A61P17/02A61P29/00A61P43/00
Inventor LANE, EDWARD M.
Owner FAIRFIELD CLINICAL TRIALS
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